Events

Device Recall Baxter Clearlink System Vented Paclitaxel Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    37362
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0618-2007
  • 사례 시작날짜
    2007-02-16
  • 사례 출판 날짜
    2007-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50416
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    IV - Product Code FPA
  • 원인
    Baxter has received reports of disconnections/leaks during use of vented paclitaxel administration sets.
  • 조치
    Baxter sent the 2/16/07 Urgent Product Recall letter to affected customers, to the attention of the Director of Nursing with copies to the Materials Manager, via first class mail to advise them of the potential disconnections/leaks during use of the Vented Paclitaxel Administration Sets. The accounts were instructed to immediately discontinue use and segregate the listed affected lot numbers, and contact Baxter Center for Service at 1-888-229-0001 to arrange for the return and credit for the affected product. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Clearlink System Vented Paclitaxel Set
  • 모델명 / 제조번호(시리얼번호)
    product code 2C8857: lots R06F05158, R06F22013, R06F22112;
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including Switzerland, Australia, Canada, Hong Kong, India, Korea, Mexico, Malaysia, New Zealand, Panama, Phillipines, Singapore, Thailand and Taiwan.
  • 제품 설명
    Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C8857
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA